Acute Lymphoblastic Leukaemia
Conditions
Interventions
Single arm: 40 treated subjects will receive intravenous infusion over 30 minutes +15 minutes of Spectrila 10 000 U/m2 body surface area (BSA).
Drug
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP
INC Research BR Serviços de Pesquisas Clínicas Ltda.
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects with newly diagnosed pathologically confirmed acute B-cell lymphoblastic leukaemia; Female or male higher or equal to 18 years of age; Eligible for treatment and treated according to the underlying treatment protocol BRALL 2014; Written informed consent given freely; Subject expresses his/her understanding of the trial procedures and willingness to abide by them during the course of the trial; Female subjects of child-bearing potential must use a highly effective method of contraception (pearl index less than 1%) in combination with a second method of contraception during the trial and for at least 3 months after Spectrila discontinuation; Men should use effective contraceptive measures and be advised to not father a child while receiving ASNase.
Exclusion criteria
Exclusion criteria: Pre-treatment with any ASNase preparation; Hypersensitivity to the active substance, Escherichia coli-ASNase preparation or to any of the excipients; Pancreatitis at the time of treatment initiation or history of pancreatitis; Pre-existing known coagulopathy; Severe liver function impairment; History of serious haemorrhage or serious thrombosis; Other current malignancies; Uncontrolled active infection; Evidence of infection with the human immunodeficiency virus, hepatitis B or C, human T-lymphotropic virus type I and II, syphilis or Chagas disease (American trypanosomiasis); Pregnancy as verified by a positive pregnancy test or nursing woman; Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely; Evidence or suspicion that the subject might not comply with the requirements of the trial protocol; Evidence or suspicion that the subject is unwilling or unable to understand the information given to him/her within the informed consent procedure; Any other factor which in the investigator’s opinion is likely to compromise the subject’s ability to participate in the trial; The subject is an employee or direct relative of an employee of the contract research organisation (CRO) involved in the trial, the trial site or medac; The subject is imprisoned or is lawfully kept in an institution; The subject has participated within 3 months before screening or plans to participate in a clinical trial (except the underlying treatment protocol BRALL 2014); Previous participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Description of proportion of induction phase responders made by evaluation of the subjects with trough levels of ASNase activity in serum higher or equal to 100 U/L in induction phase on each of the Days 23, 25, and 27 | — |
Secondary
| Measure | Time frame |
|---|---|
| Description of proportion of subjects with levels of ASNase activity in serum higher or equal to 100 U/L in induction phase before infusion of IP on Days 21 (baseline), 23 and 25 and additionally on Days 27, 29 and 31 | — |
Countries
Brazil
Contacts
Public ContactAnna Coimbra
INC Research BR Serviços de Pesquisas Clínicas Ltda.
Outcome results
None listed